217.5402 Manufacturer of investigational drug, biological product, or device may make it available to a requesting patient eligible under KRS 217.5401 to 217.5408. (1) A manufacturer of an investigational drug, biological product, or device may make the investigational drug, biological product, or device available to an eligible patient who has requested it pursuant to KRS 217.5401 to 217.5408. (2) The manufacturer may: (a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or (b) Require an eligible patient to pay the costs of or the costs associated with the manufacture of the investigational drug, biological product, or device. (3) A manufacturer shall not be required to make an investigational drug, biological product, or device available to an eligible patient. Effective: June 29, 2017 History: Created 2017 Ky. Acts ch. 65, sec. 2, effective June 29, 2017. Formerly codified as KRS 217.5403.
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